The Effect of Selenium Supplementation Among Pediatric Patients With Burns

NCT00860379 | Terminated Phase 4 Results DMC

• 1 other identifier: 2007-P-001176
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The selenium status of children with major burns is suboptimal which may increase the incidence of infection. Se requirements during critical illness are not known. Results from this investigation may provide a tool for recommending Se supplements during burn injury. The hypothesis of this research is that Se supplementation will restore the depressed Se status among children with burn injuries. The secondary hypothesis is that Se status is related to the incidence of infection among pediatric patients with burns.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Plasma Selenium

  plasma selenium of all subjects was assessed

  Average plasma selenium calculated over 8 weeks, assessed weekly.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Selenium1

EXPERIMENTAL

Subject will receive 2 ug/kg of IV selenium per day

Drug: Selenium1

Selenium2

EXPERIMENTAL

Subject will receive 4 ug/kg of IV selenium per day

Drug: Selenium2

Interventions

Selenium1 DRUG

2 ug/kg

Selenium1

Selenium2 DRUG

4 ug/kg

Selenium2

Placebo DRUG

IV saline as placebo

Also known as: saline

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 1 and 18 years of age admitted to Shriners Burns Hospital
• TBSA burn of \> 20%
• Existing IV catheter
• Enrolled into study within 3 weeks of burn injury

You may not qualify if:

• \< 1 year or \> 18 years of age
• \< 20% TBSA burn
• No existing IV catheter
• Pre-existing or acute renal disease (creatine \> 1.5 mg/dl)
• Pre-existing or acute liver disease (bilirubin \> 3)
• Pre-existing or acute thyroid disorders
• Cancer
• AIDS
• Pregnancy (as determined by routine admission labs)

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (1)

Shriners Hospitals for Children

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Maggie Dylewski Begis
• Organization: Shriners Hospitlas for Children

mdylewski@shrinenet.org

617-872-8567

Study Officials

• Maggie L Dylewski, PhD,RD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,RD

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 29, 2021
• Results First Posted: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)